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FDA OKs J&Js Tecnis PureSee Lens for Cataract Surgery

[ Price : $8.95]

FDA approves Johnson & Johnsons Tecnis PureSee Intraocular Lens, a new extended depth-of-focus lens for use in cataract surgery.

Attorneys Discuss New FDA Draft NCI Guidance

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Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and ways that some NDA and sNDA app...

Continue Modernizing Foreign Inspections: Study

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Academic researchers call on FDA to continue to modernize its foreign drug inspection program and overcome differences in inspecti...

FDA Draft Guidance for Medical Devices Intended for Weight Loss

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FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations.

AI Has Saved FDA 17,000 Hours: Makary

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FDA commissioner Marty Makary explains how the agency is using AI to modernize tedious tasks performed by humans to make drug revi...

Sen. Johnson Probing FDA Rare Disease Denials

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Senator Ron Johnson (R-WI) launches a congressional investigation into FDAs recent decisions to reject or delay treatments for rar...

FDA Opens New, Searchable Adverse Event Platform

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FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on ...

FDA OKs Bristol Myers Squibbs Sotyktu for Psoriatic Arthritis

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FDA approves Bristol Myers Squibs Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis.

4 Major Issues Plaguing FDA: Newsweek

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A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.

FDA Posts 483 Related to New Novo Nordisk Warning Letter

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FDA releases the Form 483 behind a 3/5 Warning Letter to Novo Nordisk that cited serious violations of postmarketing adverse drug ...